Objective Trials for additional or alternative treatments for cervical dystonia (CD) are scarce since the introduction of botulinum neurotoxin (BoNT). We performed the first trial to investigate whether dystonic jerks/tremor in patients with CD respond to the selective serotonin reuptake inhibitor (SSRI) escitalopram.
Methods In a randomised, double-blind, crossover trial, patients with CD received escitalopram and placebo for 6 weeks. Treatment with BoNT was continued, and scores on rating scales regarding dystonia, psychiatric symptoms and quality of life (QoL) were compared. Primary endpoint was the proportion of patients that improved at least one point on the Clinical Global Impression Scale for jerks/tremor scored by independent physicians with experience in movement disorders.
Results Fifty-threepatients were included. In the escitalopram period, 14/49 patients (29%) improved on severity of jerks/tremor versus 11/48 patients (23%) in the placebo period (P=0.77). There were no significant differences between baseline and after treatment with escitalopram or placebo on severity of dystonia or jerks/tremor. Psychiatric symptoms and QoL improved significantly in both periods compared with baseline. There were no significant differences between treatment with escitalopram and placebo for dystonia, psychiatric or QoL rating scales. During treatment with escitalopram, patients experienced slightly more adverse events, but no serious adverse events occurred.
Conclusion In this innovative trial, no add-on effect of escitalopram for treatment of CD with jerks was found on motor or psychiatric symptoms. However, we also did not find a reason to withhold patients treatment with SSRIs for depression and anxiety, which are common in dystonia.
Trial registration number NTR2178.
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Contributors EZ conducted the clinical trial, included patients, performed neurological and psychiatric examinations, conducted statistical analyses and wrote the first and final draft of the paper. JB was a direct supervisor of EZ, codesigned the trial and commented on several versions of the manuscript. CCSD, JHTMK, SMvdS, MatS and MarS were video-raters and commented on the manuscript. JMD was a video-rater, consulted on the statistical analyses and commented on the manuscript. YEMD assisted with the neurological and psychiatric examinations and commented on the manuscript. MA, HB, AJWB, JWMB, EH, AH, DJK and AGM assisted with the inclusion of patients and commented on the manuscript. JDS was a video-rater and assisted with the inclusion of patients and commented on the manuscript. MAJT was a direct supervisor of EZ, designed the trial and commented on several versions of the manuscript.
Disclaimer Lundbeck played no role in the trial design, data analysis or writing of the article.
Competing interests JHTMK has received unrestricted grants from Ipsen Pharmaceutical and Allergan Incorporated for studies and teaching workshops on dystonia. MS has received honoraria for consulting and advising from Abbvie and Medtronic, research grants from the Slovak Research and Development Agency and Slovak Scientific Grant Agency and honoraria from the International Parkinson and Movement Disorder Society, Abbvie, Egis, Krka, Lundbeck, Medtronic, Sandoz, TEVA and UCB. Other authors have no conflicts of interests to declare.
Ethics approval This study was reviewed by the local medical ethical committee (METC AMC Amsterdam).
Provenance and peer review Not commissioned; externally peer reviewed.